NCT01148199

Self-expandable Metallic Stent Versus Multiple Plastic Stents in Post Orthotopic Liver Transplantation Biliary Stenosis

Self-expandable Metalic Stent Versus Multiple Plastic Stents in Post OLT Biliary Stenosis: Prospective, Randomized, Controlled Trial.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Hospital Israelita Albert Einstein · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Biliary complications are one of the most common problems after orthotopic liver transplantation (OLT),occurring in up to 24% of patients. Anastomotic strictures have been endoscopically managed with plastic stents placement. Recently, partially and fully covered metal stents have been alternatively used to treat refractory benign biliary stenosis. The investigators purpose is to compare efficacy and safety of metallic stents versus multiple plastic stents in the endoscopic management of post transplant biliary complications.

Detailed description

Patients with biliary stricture after OLT will be randomly assigned following simple randomization to temporary placement of fully covered self-expandable metal stent (SEMS) or multiple plastic stents placement were randomized according to a computer generated randomization sequence and allocated in a 1:1 ratio to one of two treatment groups. Final success will be defined as clinical resolution of the stricture without the need to repeat endoscopic, percutaneous or surgical treatment.

Conditions

• Biliary Anastomotic Stenosis
• Biliary Stricture

Interventions

Type	Name	Description
DEVICE	Self-expandable metalic stent	Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.
DEVICE	Multiple plastic stents	Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.

Timeline

• Start date: 2009-08-01
• Primary completion: 2015-02-01
• Completion: 2016-02-01
• First posted: 2010-06-22
• Last updated: 2018-06-26

Locations

1 site across 1 country: Brazil